Spirituality and Symptom Burden in Cancer Clinical Trials Connie Ulrich, PhD, RN, FAAN, Professor of Bioethics and Nursing in the Department of Biobehavioral Health Sciences, University of Pennsylvania School of Nursing

Newly diagnosed cancer patients face many ethical challenges. They must immediately make decisions that affect their life as well as their family’s well-being. This might include chemotherapy, surgery, radiation, and even participation in cancer clinical trials. Cancer clinical trials provide an opportunity for patients to receive experimental therapies that could potentially arrest their cancer, extend their life, and even cure their disease. We surveyed 110 patient- participants enrolled in cancer clinical trials at a large Northeastern Cancer Center to better understand how their spirituality relates to a sense of hope, symptom burden and other variables. Many of our patient-participants reported that they had no or few-to-limited treatment options available to them (59.2%). And, 14.8% indicated they had no other option than to participate in the clinical trial. More than half of our participants rated their spirituality or religious beliefs as important or very important to them (57.8%). A majority of our participants (87%) experienced at least one symptom. This included more than a quarter (29.8%) who reported experiencing moderate to overwhelming pain during their research participation; 55.5% reported moderate to overwhelming symptoms including fatigue, nausea, coughing, diarrhea, constipation or nosebleeds; 60.4% rated their fatigue as 5 or higher on a visual analog scale, and slightly more than a quarter (25.8%) rated their nausea as 5 or higher. Approximately 16% of our sample had thoughts of dropping out of the trial. Spiritual optimism yields a sense of hope and may be important to patients facing a cancer diagnosis. Among those who selected that their spirituality or religious beliefs were important or very important, 95.2% (n = 60) agreed that participation in their research trial gave them a sense of hope. In contrast, only 76.0% (n=35) of those who thought spiritual beliefs as not so important agreed on the same question (p = 0.003). Participants with higher levels of symptom bother were more likely to perceive spirituality or religious beliefs as important or very important (p = .047). This trend also extends to other symptom ratings such as pain, nausea and other problems. But, does one’s faith and sense of spiritual hope or optimism comfort patients to a position of being able to tolerate life’s trials and the symptoms that may come with experimental therapies in clinical trials? Additional research is needed to determine how spiritual faith, both directly and indirectly, plays a role in symptom management for cancer patients participating in clinical trials and their ability to tolerate varying degrees of pain and other burdens they are willing to endure in the hopes of a beneficial outcome.